Losartan Recall Expands As Torrent Recalls Five More Lots

The Losartan recall continues to expand after the Food and Drug Administration (FDA) announced the recall of additional lots of the blood pressure medication due to fears of carcinogen contamination. The latest Losartan recall includes five lots manufactured by Torrent Pharmaceutical after the medication was found to contain unsafe levels of N-methylnitrosobutyric acid, or NMBA.

Why is NMBA Dangerous?

NMBA is a known animal carcinogen and believed to be a potential human carcinogen. Like NDEA and NDMA, the compounds found in previous Losartan and Valsartan recalls,  long term exposure to NMBA at unsafe levels could lead to development of certain types of cancers, including:

  • Liver Cancer
  • Stomach Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Prostate Cancer
  • Lower Esophageal Cancer
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Pancreatic Cancer

When Was this Losartan Recall Announced?

The FDA announced the latest Torrent Losartan recall on September 19, 2019, and the company issued a formal announcement of the recall on September 23. This latest recall marks the sixth time that Torrent has recalled lots of its Losartan products due to potential carcinogen contamination since the recalls began in 2018.

Which Lots of Losartan Were Recalled?

The lots included in this latest Losartan recall are listed below:

NDC
Product Name, Strength and Package Count
Batch Number
Expiration Date
13668-409-10
Losartan Potassium Tablets, USP 50mg, 1000 count
4DU2E009
12/31/2020
13668-115-90
Losartan Potassium Tablets, USP 100mg, 90 count
4DU3E009
12/31/2020
13668-115-10
Losartan Potassium Tablets, USP 100mg, 1000 count
4DU3E018
02/28/2021
13668-116-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count
BEF7D051
11/30/2020
13668-118-90
Losartan Potassium / Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count.
4P04D007
07/31/2020

GoldenbergLaw Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Losartan for at least a year, received a Losartan recall letter, and has been diagnosed with prostate cancer (before age 60), lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer. If you or a loved one has taken Losartan and been diagnosed with one of these cancers, please contact us today for a free consultation. We have over 30 years of experience holding drug manufacturers accountable for negligence, let us deliver the Gold Standard advocacy you deserve.

Oklahoma Judge Issues $572 Million Verdict in First Opioid Trial

On August 26, 2019 Oklahoma District Court Judge Thad Blakman held healthcare giant Johnson & Johnson responsible for its role in the opioid epidemic in Oklahoma by delivering a $572 million verdict in favor the state. The judge cited the aggressive marketing strategies employed by Johnson & Johnson to increase opioid sales that involved minimizing the risks of addiction and dependence, a sales strategy also known as the “addiction ditch.”

What Happened in Oklahoma?

In the first opioid epidemic case to reach trial, Oklahoma Attorney General Mike Hunter claimed that opioid overdoses killed more than 4,600 people in the state from 2007 through 2017 with thousands more currently battling opioid addiction. The state estimates that it will cost $17.5 billion over 30 years to handle the crisis through opioid use disorder screenings, prevention and treatment, recovery services, medical education, and pain management programs.

What Did Johnson & Johnson Do?

The judge found that Johnson & Johnson engaged in deceptive marketing campaigns aimed at convincing Oklahoma doctors and the public that opioids are safe and effective for long-term use and treatment of chronic pain.

In addition, Johnson & Johnson sales representatives persuaded doctors that patients’ pain symptoms were under-treated and that patients were being harmed as a result. A technique known as “pseudoaddiction” was used to convince doctors that if patients were requesting higher doses they were not necessarily addicted to the opioid, but rather they needed the higher dose to treat their pain.

In trial, the co-director for the Opioid Policy Research Collaborative at Brandeis University, Dr. Andrew Kolodny, testified that Johnson & Johnson and their proxies downplayed the risks of opioid

opioid-pill

use, exaggerated the benefits, and saturated the market with opioids. For instance, Johnson & Johnson minimized the fact that when patients take opioids every day for as few as five days,

physiological dependence begins to set in and it becomes extremely difficult to discontinue opioid use. As a result, there are now more than 2 million opioid-addicted Americans who need treatment.

What are Prescription Opioids and Why are they Dangerous?

Prescription opioids are used for moderate to severe pain relief. To achieve relief, opioid receptors attach to brain cells and release signals to block pain receptors and boost feelings of pleasure. Opioids are intended to be used for a limited time to treat pain that does not respond to standard painkillers such as Aspirin, Ibuprofen, and Paracetamol.

However, opioids are extremely addictive and can be dangerous if abused. The feelings of pleasure resulting from opioids can be addictive. As a result, the patient develops a psychological dependence on the opioids in order to achieve the feelings of pleasure. Additionally, if opioids are consumed at too high of doses, breathing and heart beat are slowed which may lead to death.

A study on opioids conducted by the Center for Disease Control and Prevention revealed the severity of the drugs’ addictiveness. In a sample of opioid naïve, cancer-free adults who received opioid prescriptions, the likelihood of chronic opioid use increased with each additional day of treatment staring with day 3 and the most drastic increase in chronic opioid use occurred after the 5th and 31st day of treatment.

What is the Opioid Epidemic?

The Center for Disease Control and Prevention reported that almost 400,000 overdose deaths in the United States between 1999 and 2017 were tied to opioids.

Startling research from the Center for Disease Control and Prevention in 2006 revealed a stark increase in opioid overdose deaths paralleling a similar increase in opioid prescriptions. Before the opioid epidemic, unintentional drug poisoning mortality rates increased on average 5.3% per year. However, at the beginning of the opioid epidemic (1990-2002), unintentional drug poisoning mortality rates increased by 18.1% per year.

Between 1999 and 2002, the number of opioid-related poisonings listed on death certificates increased by 91.2%. By 2002, opioid-related poisoning was involved in 5,528 more deaths than other addictive drugs such as heroin or cocaine.

What is Happening with Other Opioid Manufacturing Companies?

When Oklahoma initially sued to combat the opioid epidemic plaguing the state, Purdue Pharma and Teva Pharmaceuticals were named as defendants in addition to Johnson & Johnson. However, Purdue Pharma and Israel’s Teva Pharmaceuticals settled with the state prior to trial. Purdue Pharma, the maker of the blockbuster drug OxyContin, agreed to pay $270 million. Teva Pharmaceuticals, one of the world’s leading providers of generic drugs, agreed to pay $85 million.

Since Purdue Pharma did not go to trial, their marketing strategies for OxyContin were not revealed in court; however, the American Public Health Association published an analysis of their manipulative marketing tactics.

Purdue Pharma introduced the opioid OxyContin to the market in 1996 through aggressive marketing and promotion. The high availability of OxyContin correlated with increased abuse, diversion, and addiction. As a result, by 2004 OxyContin became a leading drug of abuse in the United States.

Aggressive and deceptive marketing strategies included creating individual profiles of physicians based on their prescribing patterns and creating a national database to identify the highest and lowest prescribers of particular drugs in a single zip code, county, state, or the country as a whole. After the profiles were compiled, Purdue Pharma targeted physicians who were already the highest prescribers for opioids in the country due to their large numbers of chronic-pain patients.

Purdue Pharma also introduced a lucrative bonus system which incentivized representatives to increase OxyContin sales in their region. The representatives also created a patient coupon program for OxyContin which provided patients with a free, limited-time prescription for 7 to 30 days.

These manipulative marketing tactics disguised the risk of addiction associated with opioids for the treatment of chronic pain. As a result, sales representatives were told to relay the message that the risk of addiction was “less than one percent.”  However, the studies providing these claims proved to be defunct and resulted in Purdue Frederick Company Inc. (an affiliate of Purdue Pharma) pleading guilty to criminal misbranding charges in 2007.

Dangerous Drugs and Deceptive Marketing

The $572 million verdict in Oklahoma against Johnson & Johnson is only the beginning of justice in the opioid epidemic plaguing the country. Companies who fueled the opioid epidemic by predatory marketing techniques increased the presence and availability of dangerous and addictive products. However, cities, states, and municipalities across the United States are fighting to hold those companies responsible for the devastation and predation.

 

 

GoldenbergLaw Partner Marlene Goldenberg Appointed To Valsartan MDL Leadership

Partner Marlene Goldenberg
Marlene Goldenberg

On May 6, 2019, New Jersey Federal District Court Judge Robert B. Kugler appointed GoldenbergLaw Partner Marlene Goldenberg to the Executive Committee as part of the leadership structure for the Valsartan Multidistrict Litigation (MDL). Marlene has previously served as the head of the discovery committee for the Abilify MDL in the Northern District of Florida and helped lead discovery, science, and briefing on over 800 Medtronic Infuse Bone Graft cases. Marlene and GoldenbergLaw look forward to holding these Valsartan manufacturers accountable for their actions.

Valsartan and Cancer

Valsartan (and other Sartan drugs such as Losartan and Irbesartan) are used to help treat high blood pressure and other heart-related conditions. Millions of Americans take this generic drug. Certainly no person taking this drug would take it knowing it could cause cancer.

Many of these medications are manufactured for generic companies overseas in China by Zhejiang Huahai and in India by Hetero Labs, among others. It has now been reported that for at least four years, many brands of Valsartan contained carcinogenic substances, such as NDMA, NDEA, and NBMA. These contaminated products were then sold to many companies in the U.S. for use in their sartan drugs. The U.S. companies failed to properly monitor and test their products before selling them to consumers.

How Does Contaminated Valsartan Cause Cancer?

NDMA is N-nitrosodimethylamine. It has been classified as a probable carcinogen and is often given to rats in medical studies to cause cancer! NDMA is so toxic it is contained in rocket fuel and has no approved uses in the United States. NDEA and NBMA have similar carcinogenic properties.

After consulting with some of the finest toxicologists in the country, the dose and duration of the exposure will help to determine if a patient’s cancer can be attributed to contaminated Valsartan. Unfortunately, most people take Valsartan daily and in high doses. Many American patients will have consumed enough NDMA or other nitrosamines to trigger genetic mutations and cancer.

The cancers linked to contaminated NDMA (the contaminant found in Valsartan) are digestive tract cancers where these substances would have been processed by the body. This includes liver, stomach, prostate, esophageal, and colorectal cancers. Some studies have also linked ingestion of the contaminated drugs to non-hodgkin’s Lymphoma, leukemia, and multiple myeloma.

FDA Recall

In July 2018 the FDA recalled the first Valsartan medications, but the recalls didn’t stop there. In October 2018, certain lots of Irbesartan began to be recalled. Then in December, 2018, certain batches of Losartan were recalled as well. And the recalls keep coming almost every month. Just last week, another batch of Losartan was recalled because of toxic contamination. The FDA is continuously updating the list of recalled medications.

Have You Received A Recall Letter?

Patients around the country have and continue to receive recall notices regarding their contaminated medications. If you or a loved one has received a letter, you should talk with your doctor right away about your options. If you or one of your loved ones developed liver cancer, stomach cancer, colorectal cancer, intestinal cancer, esophageal cancer, prostate cancer, pancreatic cancer, non-hodgkin’s lymphoma, leukemia, or multiple myeloma after taking Valsartan or Losartan over the past four years, please contact the Minnesota defective drug lawyers at GoldenbergLaw so we can discuss your legal rights.